Intervention to Improve Medication Adherence in Cardiovascular Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Bas Bredie, Radboud University
ClinicalTrials.gov Identifier:
NCT01449695
First received: October 5, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk cardiovascular patients.


Condition Intervention
Cardiovascular Diseases
Behavioral: Life style counseling
Behavioral: an individualized web portal
Behavioral: individual and group consultations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Change in degree of Adherence [ Time Frame: Change from baseline in degree of Adherence at 12 month ] [ Designated as safety issue: No ]
    The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: Change from baseline in level of LDL-Cholesterol at 12 months ] [ Designated as safety issue: No ]
    Change in LDL-Cholesterol level in each group at 12 months from baseline

  • Clinical outcome [ Time Frame: Change from baseline in Sytolic Blood Pressure at 12 months ] [ Designated as safety issue: No ]
    Change in Systolic Blood Pressure in each group at 12 months from baseline

  • Clinical outcome [ Time Frame: Change from baseline in Body Mass Index at 12 months ] [ Designated as safety issue: No ]
    Change in Body Mass Index (BMI) in each group at 12 months from baseline

  • Clinical outcome [ Time Frame: Change from baseline in Waist Circumference at 12 months ] [ Designated as safety issue: No ]
    Change in Waist Circumference in each group at 12 months from baseline


Estimated Enrollment: 600
Study Start Date: November 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Group consultation and individual nurse consultation
Behavioral: Life style counseling
A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants. Well-trained nurses in our hospital will apply these behavioral change interventions. An individual contact will take about twenty minutes.
Behavioral: an individualized web portal
This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient.
Behavioral: individual and group consultations
group consultations with peers and a nurse individual consultation with a nurse
Experimental: e health
An individual web based entry
Behavioral: an individualized web portal
This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient.
No Intervention: usual care
Usual care

Detailed Description:

Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time.

This study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia.

Exclusion Criteria:

  • Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449695

Contacts
Contact: Angelien Sieben, M ANP +31 (024) 3668234 a.sieben@chir.umcn.nl
Contact: Bas Bredie, MD +31 (024)3618819 s.bredie@aig.umcn.nl

Locations
Netherlands
Radboud University medical centre Recruiting
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Bas JH Bredie, MD Radboud University
  More Information

No publications provided

Responsible Party: Bas Bredie, MD, Radboud University
ClinicalTrials.gov Identifier: NCT01449695     History of Changes
Other Study ID Numbers: 34338
Study First Received: October 5, 2011
Last Updated: December 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
PAD
CVA
ACS

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014